Process Engineer III

Novartis; Durham (NC); On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis in Durham, NC is seeking a Process Engineer III to provide engineering support for manufacturing equipment, facilities, and utilities, driving reliability, compliance, and continuous improvement in a GMP pharmaceutical setting.

The role offers opportunities to lead strategic engineering initiatives, handle CIP/SIP systems, and support new product introductions while ensuring validated state and regulatory readiness.

Qualifications

• Bachelor’s degree in a related engineering field.
• 5+ years experience in pharmaceutical or biopharmaceutical GMP manufacturing.
• Strong knowledge of FDA regulations and GMP systems.
• Excellent written and verbal communication skills for technical documentation.
• Experience supporting manufacturing equipment, facilities, and utilities in pharma/biotech.
• Demonstrated project management experience leading complex initiatives.

Responsibilities

• Lead equipment lifecycle activities to ensure compliant, reliable, and validated manufacturing operations.
• Define and optimize equipment qualification and validation strategies for new and existing systems.
• Own process equipment changes to maintain validated state and drive operational improvements.
• Investigate equipment and process deviations, implementing corrective and preventive actions.
• Serve as a subject matter expert during regulatory inspections and internal audits.
• Develop and implement equipment reliability and maintenance strategies.
• Lead capital projects and provide engineering expertise for facility and equipment enhancements.
• Create and maintain technical documentation (URs, FSs, DSs).
• Partner with Operations and Manufacturing Sciences for new product introductions and facility fit assessments.

Skills

Technical communication

Project management

Regulatory compliance

Cross-functional teamwork

Data analysis

Technical writing

Education

Bachelor's degree in Chemical/Electrical/Mechanical Engineering

Tools

CIP/SIP systems

Qualification/Validation

Job description

Summary

Join a team committed to delivering life-changing therapies to patients worldwide. As a Process Engineer III, you will provide engineering support for manufacturing equipment, facilities, and utilities, driving reliability, compliance, and continuous improvement across operations. This role offers the opportunity to lead strategic engineering initiatives, solve complex technical challenges, and apply experience with fill finish/drug product equipment and Clean-in-Place (CIP)/Steam-in-Place (SIP) systems in a dynamic pharmaceutical manufacturing environment.

Summary

Join a team committed to delivering life-changing therapies to patients worldwide. As a Process Engineer III, you will provide engineering support for manufacturing equipment, facilities, and utilities, driving reliability, compliance, and continuous improvement across operations. This role offers the opportunity to lead strategic engineering initiatives, solve complex technical challenges, and apply experience with fill finish/drug product equipment and Clean-in-Place (CIP)/Steam-in-Place (SIP) systems in a dynamic pharmaceutical manufacturing environment.

About The Role

Location:

• This position will be located in Durham, NC and will be an onsite role.
• Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key Responsibilities

• Lead equipment lifecycle activities to ensure compliant, reliable, and validated manufacturing operations.
• Define and optimize equipment qualification and validation strategies for new and existing systems.
• Own process equipment changes to maintain validated state and drive operational improvements.
• Investigate equipment and process deviations, implementing effective corrective and preventive actions.
• Serve as a subject matter expert during regulatory inspections and internal audits.
• Develop and implement equipment reliability and maintenance strategies that support business objectives.
• Lead capital projects and provide engineering expertise for facility and equipment enhancements.
• Create and maintain technical documentation, including User Requirements, Functional Specifications, and Design Specifications.
• Partner with Operations and Manufacturing Sciences to support new product introductions and facility fit assessments.
• Evaluate and implement innovative manufacturing technologies to support long-term site strategy.

Essential Requirements

• Bachelor’s degree in Chemical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical field.
• Minimum five years of experience in pharmaceutical or biopharmaceutical Good Manufacturing Practice manufacturing operations.
• Strong knowledge of United States Food and Drug Administration regulations and Good Manufacturing Practice systems in regulated environments.
• Excellent written and verbal communication skills, including technical documentation and report writing.
• Experience supporting manufacturing equipment, facilities, and utility systems within pharmaceutical or biotechnology operations.
• Demonstrated project management experience with the ability to lead complex initiatives and long-term planning activities.
• Proven ability to investigate technical issues, analyze data, and implement effective solutions in fast-paced environments.
• Experience leading cross-functional teams and collaborating across multiple functions to achieve business objectives.

Desirable Requirements

• Experience supporting fill finish or drug product manufacturing equipment.
• Experience with Clean-in-Place (CIP) and Steam-in-Place (SIP) systems.

Novartis Compensation And Benefit Summary

The salary for this position is expected to range between $98,700 and $183,300 annually

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.

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EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.